Job Description :
Notes:
Red Flags: No risk assessment experience. No product complaint experience.
Interview Process: Phone & in-person interview.

Description:
Facilitate risk assessment sessions. Develop and document business processes in the form of process flows, SOPs/business practice documents, and templates.
Track, monitor and update team goals, metrics, performance boards and reports. Administration of Risk Management Training program.
Administration (if necessary) of Risk Assessment. Route risk assessment requests and ensure facilitator assignment.
Supports the development of and approves the risk assessment summary reports.
Provide broad support to the Global Quality Systems teams as needed with a core focus on Product Quality Complaint Risk Management.
This position will play a leading role in managing the execution of risk management initiatives including the facilitation of risk assessments on Client’s products with key subject matter experts including but not limiting to: Safety, Device Engineering, Device Quality and Product Quality Leaders.
Play an integral role in the classification of product complaint risk and on-going maintenance of the Product Complaints Risk Matrix.
This is a highly visible role with global responsibility and cross-functional influence that has an impact on departmental performance and broad quality initiatives requiring primarily tactical decision making.
Assist with risk identification, tracking and planning for mitigation of risks.

Requirements:
Bachelor’s Degree in Life Sciences, Business, Operations or Industrial Engineering.
5+ years biotech or pharmaceutical operations/manufacturing/process development experience.
5+ years of direct experience in project management key support roles.
Ability to analyze data with critical problem solving capabilities, product complaint experience.
Ability to interpret and evaluate data. Strong analytical and critical thinking, pattern recognition, and problem solving capabilities.
Excellent interpersonal and influencing skills. Aptitude for leading a matrixed, cross-functional team of contributors.
Comfortable dealing with senior management and across functions, global sites and disciplines.
Ability to deal with ambiguity. Familiarity with Risk Assessment tools and methods.
Demonstrated ability to work independently and without direct supervision; as well as ability to work in teams.
Ability to develop practical solutions to complex challenges. Ability to manage and prioritize multiple and diverse projects.
Ability to adapt and respond to a variety of activities/situations simultaneously.
Excellent communication, interpersonal and organization skills, and strong attention to detail.
Experience with Excel and PowerPoint.